Merck announced that it has received a positive opinion from the CHMP for its anti-PD-1 therapy Keytruda® (pembrolizumab) as monotherapy for the adjuvant treatment for adult and adolescent patients with stage IIB or IIC melanoma following complete resection. CHMP additionally recommended expansion of the Keytruda indications into advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients (12 years and older).
Days later Merck announced that the EC has approved Keytruda® (pembrolizumab) with chemotherapy as neoadjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early-stage triple-negative breast cancer at high risk of recurrence. Merck says this is the fifth approval for Keytruda in a breast or gynecologic cancer in the EU in less than a year.